The following data is part of a premarket notification filed by Shenzhen Desida Technology Co., Ltd. with the FDA for Ipl Sapphire Ice Cooling Hair Remove Device.
| Device ID | K221635 |
| 510k Number | K221635 |
| Device Name: | IPL Sapphire Ice Cooling Hair Remove Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Desida Technology Co., Ltd. 5th Floor, Building A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan Street, Baoa Shenzhen, CN 518109 |
| Contact | Shuangcheng Yuan |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Shenzhen, CN 518000 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-08-31 |